Head and Neck Cancer Clinical Trial
Official title:
Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors
NCT number | NCT04437030 |
Other study ID # | MSOT HNC |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 9, 2020 |
Est. completion date | July 1, 2023 |
Verified date | January 2024 |
Source | University Hospital Heidelberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Multispectral photoacoustic imaging enables the measurement of the optical absorption of various tissue components or exogenous contrast agents in vivo. The dominant, near infrared absorbing chromophores in human tissue are oxy- and deoxyhemoglobin followed by collagen, melanin and lipids. The multispectral measurement of the absorption of hemoglobin shows changes in blood oxygen saturation and blood volume. The high resolution of photoacoustic imaging also enables the vascular structure to be displayed. The aim of this exploratory study is to generate hypotheses by applying photoacoustic imaging to the field of head and neck tumor therapy. The next step is to investigate whether and how photoacoustic imaging can help improve diagnostics and better planning of treatments in the future. In particular, the differences between normal and tumor tissue and the changes in the tissue due to radiation therapy using photoacoustic imaging are examined. In the quantitative analysis of the images, measured chromophores, primarily oxygen saturation, blood volume and collagen concentrations at different measuring points are used in the course of the therapy.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 1, 2023 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Willingness and ability to participate 2. sufficient knowledge of German to understand the patient / subject information and the declaration of consent, 3. tumor disease to be treated by radiotherapy in the neck and neck area, 4. Completed wound healing after operative interventions in the head and neck area, 5. The patient's consent and written consent, 6. the patient's ability to assess the nature and scope as well as possible consequences of the clinical study, 8. Age = 18 years. Requirement 3 does not apply to the control group of healthy subjects Exclusion Criteria: - Pre-radiation in the head and neck area - Inadequate regression of toxicities from previous therapies - Indications that the participant is unlikely to adhere to the study protocol (e.g. lack of compliance) - Missing written declaration of consent |
Country | Name | City | State |
---|---|---|---|
Germany | University Hopsital Heidelberg | Heidelberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Heidelberg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | diagnostic feasibility of photoacoustic imaging: Oxygen Saturation | Measurement of Oxygen Saturation in the tumor tissue | previouse to Radiotherapy start | |
Primary | diagnostic feasibility of photoacoustic imaging: Oxygen Saturation | Measurement of Oxygen Saturation in the tumor tissue | 3 weeks after Radiotherapy start | |
Primary | diagnostic feasibility of photoacoustic imaging: Oxygen Saturation | Measurement of Oxygen Saturation in the tumor tissue | 3 month after Radiotherapy start | |
Primary | diagnostic feasibility of photoacoustic imaging: blood volume | blood volume | previouse to Radiotherapy start | |
Primary | diagnostic feasibility of photoacoustic imaging: blood volume | blood volume | 3 weeks after Radiotherapy start | |
Primary | diagnostic feasibility of photoacoustic imaging: blood volume | blood volume | 3 month after Radiotherapy start | |
Primary | diagnostic feasibility of photoacoustic imaging: blood volume | amount of collagen in the tumor tissue | previouse to Radiotherapy start | |
Primary | diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue | amount of collagen in the tumor tissue | 3 weeks after Radiotherapy start | |
Primary | diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue | amount of collagen in the tumor tissue | 3 month after Radiotherapy start | |
Secondary | Analysis of Tumor tissue and normal tissue | Differences of Oxygen saturation | previouse to Radiotherapy start | |
Secondary | Analysis of Tumor tissue and normal tissue | Differences of Oxygen saturation | 3 weeks after Radiotherapy start | |
Secondary | Analysis of Tumor tissue and normal tissue | Differences of Oxygen saturation | 3 month after Radiotherapy start | |
Secondary | Analysis of Tumor tissue and normal tissue | blood volume | previouse to Radiotherapy start | |
Secondary | Analysis of Tumor tissue and normal tissue | blood volume | 3 weeks after Radiotherapy start | |
Secondary | Analysis of Tumor tissue and normal tissue | blood volume | 3 month after Radiotherapy start | |
Secondary | Analysis of Tumor tissue and normal tissue | amount of collagen | previouse to Radiotherapy start | |
Secondary | Analysis of Tumor tissue and normal tissue | amount of collagen | 3 weeks after Radiotherapy start | |
Secondary | Analysis of Tumor tissue and normal tissue | amount of collagen | 3 month after Radiotherapy start | |
Secondary | multimodal information about tissue morphology | Registration of photoaccustic and MRI/CT Imaging | previouse to Radiotherapy start | |
Secondary | multimodal information about tissue function | Registration of photoaccustic and MRI/CT Imaging | 3 weeks after Radiotherapy start | |
Secondary | multimodal information about tissue function | Registration of photoaccustic and MRI/CT Imaging | 3 month after Radiotherapy start |
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